Lung Surfactant

Treatment of respiratory distress syndrome (RDS) in premature infants

No known contraindications

Marked improvement in oxygenation may occur within minutes of administration, therefore, may require frequent clinical and laboratory assessment so adjustments to oxygen delivery and ventilation settings can be made. Should only be used by those who are experts in care of the premature infant. Stop administration if bradycardia, hypotension, endotracheal tube blockage, or oxygen desaturation occur. May reinstitute after the patient is stable. Correct acidosis, hypotension, anemia, hypoglycemia, and hypothermia before use. Do not use with experimental therapies for RDS.

Percentage unknown:

Respiratory: Endotracheal tube blockage, oxygen desaturation

There have been no reports. However, in the event of an accidental overdose in which the patient has suffered clinical effects, aspirate as much of the suspension from the lungs as possible and manage with supportive treatment, with emphasis on fluid and electrolyte balance.

Stored under refrigeration at defined temperature of 2°C to 8°C (36°F to 46°F). Unopened, unused vials that have been warmed to room temperature can be returned to refrigerator storage within 24 hours for future use. Do not warm and then refrigerate more than once. Protect from light. Do not shake.

Endogenous pulmonary surfactant reduces surface tension at the air-liquid interface of the alveoli during ventilation and stabilizes the alveoli against collapse at resting transpulmonary pressures. A deficiency of pulmonary surfactant in preterm infants results in respiratory distress syndrome characterized by poor lung expansion, inadequate gas exchange, and atelectasis. Poractant alpha compensates for the surfactant deficiency and restores surface activity to the infant's lungs. It reduces mortality and pneumothoraces associated with RDS.

Information limited to animal models. No human information about pharmacokinetics exists.

Intratracheal use only: Premature infant with RDS: Initial dose is 2.5 mL/kg of birth weight. Up to 2 subsequent doses of 1.25 mL/kg birth weight can be administered at 12-hour intervals if needed in infants who continue to require mechanical ventilation and supplemental oxygen.

Take from refrigerator and warm to room temperature. Inspect for discoloration. The color should be white to creamy white. Gently turn the vial upside down to get a uniform suspension. Do not shake. Slowly withdraw the entire contents into a 3 or 5 mL plastic syringe through a large gauge needle ( greater than or equal to 20 gauge). The drug is administered intratracheally through a 5-French end-hole catheter cut to a standard length of 8 cm.

Attach the catheter to the syringe. Fill the catheter with poractant alfa. Discard the excess through the catheter so that only the total dose to be given remains in the syringe.

Before administering, assure proper placement and patency of the endotracheal tube. The endotracheal tube may be suctioned before administering the poractant alpha. The infant should be stable before proceeding with dosing. The infant's ventilator settings should be changed to a rate of 40-60 breaths/minute, inspiratory time 0.5 seconds, and supplemental oxygen to maintain SaO₂ of 92%. Keep the head and body of the infant in alignment without inclination. Briefly disconnect the endotracheal tube from the ventilator, insert the 5-French catheter. This catheter is inserted into the infant's endotracheal tube with the tip positioned distally in the endotracheal tube. The catheter tip should not extend beyond the distal tip of the endotracheal tube. Each dose should be administered in two aliquots with each aliquot administered into one of the two main bronchi by positioning the infant with either the right or left side dependent.

Insert the first aliquot (1.25 mL/kg birth weight) and position the infant so that either the right or left side is dependent for the aliquot. Remove the catheter and manually ventilate the infant with 100% oxygen at a rate of 40-60 breaths/minute for 1 minute. When the infant is stable, reposition the infant such that the other side is dependent and administer the remaining aliquot using the same technique. Remove the catheter without flushing. Do not suction the airways for 1 hour after instillation unless signs of significant airway obstruction occur. Resume ventilator management and clinical care.

Up to 2 repeated doses may be administered, using the same technique at 12-hour intervals.

Arterial blood gases, ventilator measurement assessment

No information available to require special precautions

No effects or complications reported

See administration for details. Monitor vital signs. If the patient becomes bradycardic, hypotensive, has reduced oxygen saturation, or signs of endotracheal or airway obstruction, stop administration and stabilize the patient. Dosing may resume when patient stabilizes.

Suspension; inhalation: 1.5 mL, 3 mL